There are many ways in which a product can be deemed defective. Sometimes, only a single defective product results from a manufacturing error. In other words, something went wrong during the process of making the product.

In other cases, all of the products in a particular line are found to be defective due to a poor design or perhaps a failure to warn. Recently, a Massachusetts appellate court reviewed a trial court’s decision declaring a medical device defective due to its design and lack of a proper warning.

Facts of the Case

In the recent case of Albright v. Boston Scientific Corporation, the plaintiff filed suit in 2012, seeking damages for injuries that she allegedly sustained after having a pelvic floor repair device made by the defendant (a Massachusetts-based company) surgically implanted to treat her pelvic organ prolapse condition. The purpose of the device was to shore up and repair the tissue that held and supported the plaintiff’s pelvic organs. It was cleared for sale in the United States by the Federal Drug Administration (FDA).

According to the plaintiff’s complaint, the defendant designed, manufactured, and marketed the repair device. It also sold it to the Ohio hospital where the plaintiff’s surgery was performed. The case was tried to a jury. After a three-week trial, the jury found in the defendant’s favor, rejecting the plaintiff’s assertions that the repair device had a defective design and an inadequate warning. The plaintiff appealed, challenging the trial court’s exclusion of a medical application caution found in a 2004 material safety data sheet (MSDS).

Decision of the Massachusetts Appeals Court

The court agreed with the plaintiff that, in the context of the case as it unfolded at trial, the lower court committed prejudicial error in excluding the caution (and FDA letters) proffered by the plaintiff. The MSDS caution stated, in effect, that the polypropylene with which the device was made should not be used in medical applications involving permanent contact with internal tissues. Accordingly, the court vacated the trial court’s judgment in favor of the defendant and remanded the case to the lower court with directions that a new trial be held.

Since the plaintiff’s surgery had taken place in Ohio, the court looked at the law of that state to resolve the issues before it but acknowledged that Massachusetts trial judges have wide discretion in ruling on the admissibility of evidence. With regard to the MSDS caution, the court found that the proffered evidence should have been admitted for the limited purpose of showing that the defendant had notice of the content of the MSDS well before the time of the plaintiff’s surgery.

To Talk to a Cape Cod Negligence Attorney

If you or a loved one has been hurt by a defective product, you should speak to an attorney about your legal right to seek compensation from the manufacturer, seller, or supplier of the product. To schedule a confidential case evaluation, call the Law Offices of John C. Manoog, III, at (888) 262-6664 and ask for a free consultation with one of our experienced Cape Cod product liability attorneys. No legal fees are due unless your case is successfully resolved via settlement or judgment.